Overwhelmed -Compliance, Collaboration and the FDA


By Sven Larsen

Recently, the FTC announced that bloggers must disclose any gifts or free product samples they receive from a company when writing a product review or endorsement. The new ruling probably wont have much of an effect on Pharma bloggers (I dont expect to be receiving free samples of Mercks latest anti arthritis drug any time soon) but it does bring up the larger issue of compliance.

The FTC faces the same challenge that the FDA faces when they use regulation to compel Pharma companies to respond to adverse effect postings on the web. Traditionally, Pharmaceutical companies have steered clear of social media because of these regulatory requirements. But now the evolution of the various social networks and platforms has changed the shape of that risk somewhat. With over 500 million Facebook users, the challenge of responding to adverse effects posting is so daunting that it now makes more sense to try and create centralized destinations for treatment discussions than trying to comb the entire World Wide Web. At least, if a company creates a site where their latest cancer treatment is being discussed, they have a better chance of monitoring the conversation and responding to any patient concerns.

While I feel pharmaceutical companies bear a tremendous responsibility to their patients to respond to adverse effects and fully disclose any risks associated with use of their product, I do feel that the current regulatory environment is out of touch with the reality of the digital space. I dont expect the FTC to spend billions of dollars of taxpayer money creating a team of “blog inspectors to comb the literally millions of product review blogs on the web. And I think its unrealistic for the FDA to expect manufacturers to comb billions of pages monitoring conversations about their products. Its an impossible task and full compliance would put an enormous financial drain on pharmaceutical companies. That financial burden would mean companies would have to take away money from R & D and ultimately, it would harm the public as much as it would help it.

The FDA is set to have hearings on social media soon. This is a very positive step and one, I hope, that acknowledges the new digital world we are all now living in. Its time to create a new set of regulations that more accurately reflect the environment in which pharmaceutical companies deal with dialogue about their product. Its also time to create a series of guidelines for anyone writing on topics like healthcare and patient treatment.

Consider this. In the democratic world of the web, anyone can write about cancer, diabetes or any disease state they choose. And they can write about any treatment option they choose. But how many of these new bloggers or Facebook community leaders are aware of the FDA regulations regarding Pharma communications? Isnt it time that the Pharmaceutical industry and the FDA joined forces to educate the general public on our industrys responsibilities to the people using our products? Isnt it time that we let them know that complaints about adverse effects (or any other issues with a product) need to be directed to the manufacturer on a channel where they can easily receive and respond to that complaint? Isnt it time we evolved into a new less, adversarial relationship with the FDA and joined forces to ensure that any report of an adverse effect receives the proper attention?

The alternative is condemning Pharma companies to the impossible task of monitoring the entire world of digital communications for these types of reports. And the FDA will be similarly doomed to conduct the same monitoring operation and enforcing its compliance regulations. We all know that this is an impossible task and that both parties will miss many reports.

Which solution would you rather pursue? Is there another way we can make sure that we use the digital tools weve been given to respond to patient complaints?

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